Platelet DysfunctionPhase 2/3EDGENCT04400760
The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.
A Phase 2/3 study testing DAPA Tx in people with Platelet Dysfunction, run by The University of The West Indies at 1 site in Trinidad and Tobago.
Trial summary
Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, reduce the likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of which the mechanism has not been fully elucidated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet Dysfunction
- What is being tested?
- DAPA Tx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- 1 May 2020to 30 Jun 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18 and 74 years of age,
- have stable coronary artery disease and diabetes mellitus, already on DAPT with aspirin and clopidogrel for at least 6 months,
- not on any physician-prescribed medications or complementary/alternative therapies.
Who cannot join
- presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding,
- history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm,
- history of clinical and/or hemodynamic instability,
- within 1 month of placement of a bare-metal stent,
- within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,
- planned coronary revascularization,
Show all 15Show fewer
- treatment with fibrin-specific fibrinolytic therapy <24 h or non-fibrin-specific fibrinolytic therapy <48 h,
- use of an oral anticoagulation agent or international normalized ratio >1.5,
- body weight <60 kg,
- age >75 years,
- hemoglobin <10 g/dL,
- platelet count <100×106/μL,
- creatinine >2 mg/dL,
- hepatic enzymes >2.5 times the upper limit of normal,
- pregnancy and/or lactation.
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
Eric Williams Medical Sciences Complex
Port of Spain, North Central, 00000
About this study
Official title: The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.
Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, reduce the likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of which the mechanism has not been fully elucidated. The mechanistic effects of dapagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.
Read the detailed description
Diabetes is highly prevalent in our setting. Dapagliflozin is now considered first-line treatment for diabetes, especially in the cardiovascular arena. The standard prescribed dosages of dapagliflozin will be employed in the research study (5 or 10 mg once daily). The reason the study team is interested in performing this study in our local setting is that if dapagliflozin does show a beneficial effect with either diabetic control or an antiplatelet effect, the team can then inform the Ministry of Health to acquire these relatively expensive medications in place of the older, less effective anti-diabetic drugs. The team has to demonstrate that they work effectively and safely in our population before approaching regulatory bodies with a robust recommendation that they are made available in the public healthcare sector. The patients that are to be selected will be relatively controlled on their current regimen, and thus not "miss out" on these medications after the study has been concluded as they are all available on the chronic disease assistance program (CDAP) such as metformin, gliclazide and insulin therapies. The study will aim to determine if dapagliflozin does demonstrate other latent antiplatelet effects that can potentially affect the cardiovascular/hematologic systems that have not investigated before.
- Conditions
- Platelet Dysfunction
- Being tested
- DAPA Tx
- Keywords
- dapagliflozin, SGLT2i
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPA TxDrug
The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| DAPA Tx | Other | This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks. Receives: Drug: DAPA Tx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx
Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin
Measured: Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 May 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Platelet DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be of a prospective, open-label trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago will be screened for potential eligibility.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen Seecheran, The University of The West Indies
- Investigators
- Naveen A Seecheran, MBBS MSc, Principal investigator, The University of The West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400760
- Sponsor's protocol ID
- CREC-SA.0284/03/2020
- Acronym
- EDGE
- Status last verified
- Oct 2023
- First submitted
- 19 May 2020
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Seecheran N, Grimaldos K, Ali K, Grimaldos G, Richard S, Ishmael A, Gomes C, Karan A, Seecheran R, Seecheran V, Persad S, Abdullah H, Peram L, Dookeeram D, Giddings S, Motilal S, Raza S, Tello-Montoliu A, Schneider D. The Effect of Dapagliflozin on Platelet Function Testing Profiles in Diabetic Patients: The EDGE Pilot Study. Cardiol Ther. 2021 Dec;10(2):561-568. doi: 10.1007/s40119-021-00242-6. Epub 2021 Oct 13.
PubMed 34643895
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.
- ClinicalTrials.gov ID
- NCT04400760
- Acronym / sponsor ID
- EDGE / CREC-SA.0284/03/2020
- Conditions
- Platelet Dysfunction
- Keywords
- dapagliflozin, SGLT2i
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, reduce the likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of which the mechanism has not been fully elucidated. The mechanistic effects of dapagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.
Detailed description
Diabetes is highly prevalent in our setting. Dapagliflozin is now considered first-line treatment for diabetes, especially in the cardiovascular arena. The standard prescribed dosages of dapagliflozin will be employed in the research study (5 or 10 mg once daily). The reason the study team is interested in performing this study in our local setting is that if dapagliflozin does show a beneficial effect with either diabetic control or an antiplatelet effect, the team can then inform the Ministry of Health to acquire these relatively expensive medications in place of the older, less effective anti-diabetic drugs. The team has to demonstrate that they work effectively and safely in our population before approaching regulatory bodies with a robust recommendation that they are made available in the public healthcare sector. The patients that are to be selected will be relatively controlled on their current regimen, and thus not "miss out" on these medications after the study has been concluded as they are all available on the chronic disease assistance program (CDAP) such as metformin, gliclazide and insulin therapies. The study will aim to determine if dapagliflozin does demonstrate other latent antiplatelet effects that can potentially affect the cardiovascular/hematologic systems that have not investigated before.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be of a prospective, open-label trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago will be screened for potential eligibility.
| Arm | Type | Receives |
|---|---|---|
| DAPA Tx | Other | Drug: DAPA TxThis arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18 and 74 years of age,
- have stable coronary artery disease and diabetes mellitus, already on DAPT with aspirin and clopidogrel for at least 6 months,
- not on any physician-prescribed medications or complementary/alternative therapies.
Key exclusion criteria (15 listed)
- presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding,
- history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm,
- history of clinical and/or hemodynamic instability,
- within 1 month of placement of a bare-metal stent,
- within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAPA TxThe intervention, dapagliflozin will be administered 10mg per oral daily for two weeks. | Drug | DAPA Tx |
Primary outcome
Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx
Time frame: Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin
Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34643895Seecheran N, Grimaldos K, Ali K, Grimaldos G, Richard S, Ishmael A, Gomes C, Karan A, Seecheran R, Seecheran V, Persad S, Abdullah H, Peram L, Dookeeram D, Giddings S, Motilal S, Raza S, Tello-Montoliu A, Schneider D. The Effect of Dapagliflozin on Platelet Function Testing Profiles in Diabetic Patients: The EDGE Pilot Study. Cardiol Ther. 2021 Dec;10(2):561-568. doi: 10.1007/s40119-021-00242-6. Epub 2021 Oct 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen A Seecheran, MBBS MSc principal investigator
The University of The West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DAPA Tx in people with Platelet Dysfunction, run by The University of The West Indies at 1 site in Trinidad and Tobago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Trinidad and Tobago. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx (time frame: Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.